Tiêu chuẩn iso 17510 1 2007

Microsoft Word C041615e doc Reference number ISO 17510 1 2007(E) © ISO 2007 INTERNATIONAL STANDARD ISO 17510 1 Second edition 2007 10 01 Sleep apnoea breathing therapy — Part 1 Sleep apnoea breathing[.]

Reference numberISO 17510-1:2007(E)

Second edition2007-10-01

Sleep apnoea breathing therapy —

`,,```,,,,````-`-`,,`,,`,`,,` -PDF disclaimer

This PDF file may contain embedded typefaces In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy The ISO Central Secretariat accepts no liability in this area

Adobe is a trademark of Adobe Systems Incorporated

Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing Every care has been taken to ensure that the file is suitable for use by ISO member bodies In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below

COPYRIGHT PROTECTED DOCUMENT

© ISO 2007

All rights reserved Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester

ISO copyright office

Case postale 56 • CH-1211 Geneva 20

`,,```,,,,````-`-`,,`,,`,`,,` -Contents Page

Foreword v

Introduction vi

1 * Scope 1

2 Normative references 1

3 Terms and definitions 3

4 Requirements 4

5 Classification and designation 4

6 Marking, labelling and packaging 4

7 Power input 8

8 Basic safety categories 8

9 Removable protective means 8

10 Environmental conditions 8

11 Not used 9

12 Not used 9

13 General 9

14 Requirements related to classification 9

15 Limitation of voltage and/or energy 9

16 Enclosures and protective covers 9

17 Separation 9

18 Protective earthing, functional earthing and potential equalization 9

19 Continuous leakage currents and patient auxiliary currents 9

20 Dielectric strength 10

21 Mechanical strength 10

22 Moving parts 10

23 Surfaces, corners and edges 10

24 Stability in normal use 10

25 Expelled parts 10

26 * Vibration and noise 10

27 Pneumatic and hydraulic power 11

28 Suspended masses 11

29 X-radiation 11

30 Alpha, beta, gamma, neutron radiation and other particle radiation 11

31 Microwave radiation 11

32 Light radiation (including lasers) 12

33 Infra-red radiation 12

`,,```,,,,````-`-`,,`,,`,`,,` -34 Ultra-violet radiation 12

35 Acoustical energy (including ultra-sonics) 12

36 Electromagnetic compatibility 12

37 Locations and basic requirements 12

38 Marking, accompanying documents 12

39 Common requirements for Category AP and Category APG equipment 12

40 Requirements and tests for category AP equipment, parts and components thereof 12

41 Requirements and tests for category APG equipment, parts and components thereof 13

42 Excessive temperatures 13

43 Fire prevention 13

44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 13

45 Pressure vessels and parts subject to pressure 14

46 Human errors 14

47 Electrostatic charges 14

48 Biocompatibility 15

49 Interruption of the power supply 15

50 Accuracy of operating data 15

51 Protection against hazardous output 15

52 Abnormal operation and fault conditions 16

53 Environmental tests 16

54 General 16

55 Enclosures and covers 17

56 Components and general assembly 17

57 Mains parts, components and layout 19

58 Protective earthing — Terminals and connections 19

59 Construction and layout 19

Annex AA (informative) Rationale 20

Annex BB (normative) * Pressure accuracy in normal use test methods 25

Annex CC (normative) Maximum flowrate test method 27

Annex DD (informative) Environmental aspects 28

Annex EE (informative) Reference to the essential principles 30

Annex FF (informative) Terminology – Alphabetized index of defined terms 32

Bibliography 34

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies) The work of preparing International Standards is normally carried out through ISO technical committees Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2

The main task of technical committees is to prepare International Standards Draft International Standards adopted by the technical committees are circulated to the member bodies for voting Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights ISO shall not be held responsible for identifying any or all such patent rights

ISO 17510-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment

This second edition cancels and replaces the first edition (ISO 17510-1:2002) which has been technically revised

ISO 17510 consists of the following parts, under the general title Sleep apnoea breathing therapy:

⎯ Part 1: Sleep apnoea breathing therapy equipment

⎯ Part 2: Masks and application accessories

`,,```,,,,````-`-`,,`,,`,`,,` -Introduction

Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during sleep The awareness of the risks associated with sleep apnoea has grown significantly in recent years As a result, the use of sleep apnoea breathing therapy equipment has become common This document covers basic safety and essential performance requirements needed to protect patients in the use of this equipment

This document is a Particular Standard based on IEC 60601-1:1988, including Amendments 1 (1991) and 2 (1995), hereafter referred to as the General Standard The General Standard is the basic document for the safety of medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment It also contains certain requirements for reliable operation to ensure safety

The General Standard has associated Collateral Standards and Particular Standards The Collateral Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment, such as medical electrical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc The Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc

NOTE Definitions of Collateral Standard and Particular Standard can be found in IEC 60601-1:1988, 1.5 and A.2, respectively

To facilitate the use of this document, the following drafting conventions have been applied

This document uses the same main clause titles and numbering as the General Standard, for ease of referencing of the requirements The changes to the text of the General Standard, as supplemented by the Collateral Standards, are specified by the use of the following words

cross-⎯ “Replacement” means that the indicated clause or subclause of the General Standard is replaced completely by the text of this document

⎯ “Addition” means that the relevant text of this document is supplementary to the requirements of the General Standard

⎯ “Amendment” means that existing text of the General Standard is modified as indicated by the text of this document

To avoid confusion with any amendments to the General Standard itself, a particular numbering has been employed for elements added by this document: subclauses, tables and figures are numbered starting from 101; additional list items are lettered aa), bb), etc., and additional annexes are lettered AA, BB, etc

Throughout this document, text for which a rationale is provided in Annex AA is indicated by an asterisk (*)

Sleep apnoea breathing therapy —

Part 1:

Sleep apnoea breathing therapy equipment

1 * Scope

IEC 60601-1:1988, Clause 1 applies, except as follows

Amendment (add at the end of the Subclause 1.1):

This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions

This part of ISO 17510 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates

Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510

This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including:

This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12

ISO 17510 covers sleep apnoea breathing therapy equipment for patient use ISO 17510-2 applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient See also Figure AA.1

2 Normative references

The following referenced documents are indispensable for the application of this document For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (including any amendments) applies

ISO 32, Gas cylinders — Colour coding

ISO 3744:1994, Acoustics — Determination of sound power levels of noise sources using sound pressure —

Engineering method in an essentially free field over a reflecting plane

`,,```,,,,````-`-`,,`,,`,`,,` -ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary

ISO 4871, Acoustics — Declaration and verification of noise emission values of machinery and equipment ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded

weight-bearing connectors

ISO 5359, Low-pressure hose assemblies for use with medical gases

ISO 8185:2007, Respiratory tract humidifiers for medical use — Particular requirements for respiratory

humidification systems

ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed

medical gases and vacuum

ISO 11135 (both parts), Sterilization of health care products — Ethylene oxide

ISO 11137 (all parts), Sterilization of health care products — Radiation

ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing

agent and the development, validation and routine control of a sterilization process for medical devices

ISO 14971:2007, Medical devices — Application of risk management to medical devices; Amendment 1, 2003 ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and

information to be supplied — Part 1: General requirements

ISO/TR 16142:2006, Medical devices — Guidance on the selection of standards in support of recognized

essential principles of safety and performance of medical devices

ISO 17510-2:2007, Sleep apnoea breathing therapy — Part 2: Masks and application accessories

ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for the

processing of resterilizable medical devices

ISO 17665 (both parts), Sterilization of health care products — Moist heat

ISO 23328-1, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to

assess filtration performance

ISO 23328-2, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects IEC 60079-4, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition

temperature; Amendment 1, 1995

IEC 60529, Degrees of protection provided by enclosures (IP Code); Amendment 1:1999

IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety and essential

performance; Amendment A1:1991; Amendment A2:1995

IEC 60601-1-1:2000, Medical electrical equipment — Part 1-1: General requirements for safety — Collateral

Standard: Safety requirements for medical electrical systems

IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and

essential performance — Collateral Standard: Electromagnetic compatibility — Requirements and tests

IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential

performance — Collateral standard: Usability

`,,```,,,,````-`-`,,`,,`,`,,` -IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and

essential performance — Collateral Standard: General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 61672 (all parts), Electroacoustics — Sound level meters

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 4135, ISO 14971, ISO 17510-2, ISO 23328-2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and the following apply

NOTE For convenience, the sources of all defined terms used in this document are given in Annex FF

3.1

* applied part

part of the equipment which in normal use:

⎯ necessarily comes into physical contact with the patient for the equipment to perform its function or

⎯ can be brought into contact with the patient or

⎯ needs to be touched by the patient or

⎯ is intended to be connected to the patient connection port of the sleep apnoea breathing therapy equipment

[Modified from IEC 60601-1/A2:1995, definition 2.1.5]

3.2

bi-level positive airway pressure

two therapeutic positive pressure levels at the patient connection port during the respiratory cycle

3.3

breathing gas pathway

pathway through which gas flows at respiratory pressures between the fresh-gas intake port and the patient connection port

sleep apnoea breathing therapy equipment

equipment intended to alleviate the symptoms of patients who suffer from sleep apnoea by delivering a therapeutic breathing pressure to the patient

NOTE Sleep apnoea breathing therapy equipment is primarily used without direct professional supervision when a patient is at home

4 Requirements

IEC 60601-1:1988, Clauses 3 and 4 apply

5 Classification and designation

IEC 60601-1:1988, Clause 5 applies

6 Marking, labelling and packaging

IEC 60601-1:1988, Clause 6 applies, except as follows

6.1 Marking on the outside of equipment or equipment parts

e) Identification of the origin

Replacement:

The address and name or trade-mark of the manufacturer or supplier or of the authorized representative of the manufacturer who claims that the equipment complies with this document

Addition:

aa) Flow-direction sensitive components

All operator-interchangeable flow-direction sensitive components shall be permanently marked with a clearly legible arrow indicating the correct direction of flow

bb) High-pressure input port

Any high-pressure input port shall be marked on or in the vicinity with the name or symbol of the gas as given

in ISO 5359 with the rated range of supply pressures in kilopascals and with the maximum flowrate requirement in litres per minute

cc) Operator-accessible ports

If an operator-accessible port is provided, it shall be marked Appropriate pictograms or symbols may be used

dd) * Label of the equipment or detachable parts

The label shall contain the following:

⎯ if the intended purpose of the equipment is not obvious to the operator, the detachable part or its package shall be provided with an instruction leaflet or operating instructions;

⎯ the name or trade name and address of the manufacturer and the name and address of the person responsible or of the authorized representative of the manufacturer or importer;

⎯ equipment identification and content information;

⎯ where appropriate, symbols 5.20 to 5.24 from ISO 15223-1:2007;

⎯ where appropriate, an identification reference to the batch or serial number, or symbols 5.14 or 5.16 from ISO 15223-1:2007;

`,,```,,,,````-`-`,,`,,`,`,,` -⎯ where appropriate, an indication of the latest date by which the equipment can be used, expressed as the year and month;

⎯ where appropriate, an indication that the equipment is for single or multiple patient use only;

⎯ any special storage and/or handling conditions;

⎯ any warning and/or precaution to take;

⎯ equipment which is considered to constitute active medical devices, year of manufacture or symbol 5.13 from ISO 15223-1:2007, except those covered by 6.1 dd) 6th dash;

NOTE This indication can be included in the batch code or serial number

⎯ where applicable, recommended methods of cleaning and disinfection or cleaning and sterilization shall

be specified;

⎯ where applicable, use of an appropriate breathing system filter shall be specified;

⎯ where applicable, methods of cleaning the breathing system filter shall be specified;

⎯ equipment packaging and/or labelling shall differentiate between the same or similar products placed on the market, both sterile and non-sterile;

⎯ for equipment and its parts, marking regarding their proper disposal;

⎯ if provided, gas-specific colour-coding of flowrate controls and flexible hoses in accordance with ISO 32

6.2 Marking of controls and instruments

g)

Amendment (add at the end of the list):

Airway pressures shall be marked in both an SI unit and centimetre water (cm H2O) The units of measure may be selectable

6.8.2 Instructions for use

Amendment (add at the end of the list item):

d) * Cleaning, disinfection and sterilization of parts in contact with the patient

If applicable, the instructions for use shall contain:

⎯ information about cleaning and disinfection or sterilization of equipment and accessories prior to first use;

⎯ information about cleaning and disinfection or cleaning and sterilization and any restriction concerning re-use, including any specific procedure(s) necessary before the equipment and accessories are transferred to another patient;

⎯ instructions that indicate the maximum number of reprocessing cycles of cleaning, disinfection and sterilization before a component can no longer be used, or instructions that indicate the visual or functional pass/fail criteria to be used in determining when a component can no longer be used after reprocessing

`,,```,,,,````-`-`,,`,,`,`,,` -Addition:

aa) The instructions for use shall additionally include the following:

⎯ the form and the dimensions of the patient connection port [see 56.3 ee)];

⎯ * the maximum flowrate at pressures of the minimum, ¼, ½, ¾ and the maximum of adjustable pressure (rounded up to the next whole integer) under the conditions specified in Annex CC, expressed in tabular form (see Table CC.1);

⎯ pressure accuracy under the static long-term and dynamic short-term conditions derived from the tests as specified in BB.1 and BB.2;

NOTE This information is expressed in tabular form

⎯ for equipment with an integrated humidifier, all results shall be given with the humidifier filled halfway between the minimum and maximum and operating in normal use;

⎯ for equipment that is recommended for use with a humidifier, all results shall be given without a humidifier as well as with any humidifier recommended in the instructions for use, filled halfway between the minimum and maximum and operating in normal use

⎯ unless not applicable, a warning to the effect that appropriate masks and accessories must be used with the equipment to ensure the delivery of the therapeutic pressure and to minimize CO2 rebreathing;

⎯ information concerning the disposal of the equipment and components (e.g battery)

bb) The maximum achievable pressure at the patient connection port under normal and single fault conditions

(see 51.101)

cc) If there is no respiratory pressure measuring device, the manufacturer shall declare the stability of

pressure control between recommended maintenance times

NOTE This requirement applies whether or not the respiratory pressures are adjustable by the patient

dd) The maximum A-weighted sound pressure level and sound power level measured as described in

Clause 26

ee) The extreme conditions of operation (see 10.102)

ff) The humidification system output if the sleep apnoea breathing therapy equipment contains an integral

humidifier

gg) For equipment not intended for use in conjunction with oxidants (see Clause 43), a warning to the effect

that sources of oxygen should be located more than 1 m from the equipment

hh) If provided, the exchange interval of the air inlet filter

ii) Information about the nature and frequency of regular and preventative maintenance of the equipment,

including information about the replacement of consumable components of the equipment during its intended life

`,,```,,,,````-`-`,,`,,`,`,,` -6.8.3 Technical description

Addition:

aa) Additional general information:

The technical description shall include the following:

⎯ all information necessary to check that the equipment is installed correctly and is in safe and correct working order;

⎯ the maximum steady limiting pressure (Plim, max) when tested as described in 51.101;

⎯ if appropriate, the means of triggering;

⎯ the purpose, type, range and sensing position of all measuring and display devices, either incorporated into the equipment or recommended by the manufacturer for use with the equipment including the description(s) of the interface(s) necessary for equipment set-up and safe operation;

⎯ unless measured or displayed parameters are expressed under ATPD1) conditions, the conditions under which they are expressed (e.g BTPS2));

⎯ description of operator-detachable breathing gas pathway components including breathing system filters;

⎯ functional diagram of the pneumatic flow path through the equipment;

⎯ details of any restrictions on the sequence of components within the breathing gas pathway, e.g where such components are flow-direction sensitive;

⎯ interdependence of controls;

⎯ accuracies and ranges of displayed values and calibrated controls;

NOTE The accuracy could be expressed in the form of maximum zero error (bias) quoted in appropriate units plus a sensitivity error, e.g quoted as percentage of the reading

⎯ if applicable, battery life and description of battery replacement and charging;

⎯ equipment function after interruption and restoration of the power supply;

bb) if appropriate, a statement to the effect that combinations with other medical devices can alter the

performance of the equipment, e.g combinations with humidifier, filters, heat and moisture exchangers, breathing system filters or exhaust ports other than recommended

cc) A statement on proper disposal at the end of the equipment's life

1) ATPD: Ambient Temperature and Pressure, Dry

2) BTPS: Body Temperature and Pressure, Saturated

`,,```,,,,````-`-`,,`,,`,`,,` -7 Power input

IEC 60601-1:1988, Clause 7 applies

8 Basic safety categories

IEC 60601-1:1988, Clause 8 applies

9 Removable protective means

IEC 60601-1:1988, Clause 9 applies

10 Environmental conditions

IEC 60601-1:1988, Clause 10 applies, except as follows

10.1 Transport and storage

Amendment (add at end of paragraph):

Packaging of sterile equipment or equipment parts shall ensure sterile conditions until opened or damaged or until its expiration date is reached

Consideration should be given to the disposal of packaging waste

Addition:

10.101 Electrical and pneumatic driving power supplies

The equipment shall continue to function within the specified tolerances throughout the range of supply variation specified by the manufacturer

10.102 * Operation under extreme conditions

Outside the environmental and supply conditions specified in IEC 60601-1:1988, 10.2, but within the limits stated below, the equipment shall not cause a safety hazard to the patient or operator

⎯ ambient temperature range of 5 °C to 40 °C;

⎯ ambient relative humidity range of 15 % RH to 95 % RH;

⎯ AC supply voltage range of −15 % to +10 % of declared nominal value;

⎯ DC supply voltage range of −15 % to +25 % of declared nominal value

NOTE The equipment might continue to function but not within the specified pressure accuracy requirements

`,,```,,,,````-`-`,,`,,`,`,,` -11 Not used

12 Not used

13 General

IEC 60601-1:1988, Clause 13 applies

14 Requirements related to classification

IEC 60601-1:1988, Clause 14 applies, except as follows

14.1 Class I equipment

Replacement:

Sleep apnoea breathing therapy equipment shall not be class I

15 Limitation of voltage and/or energy

IEC 60601-1:1988, Clause 15 applies

16 Enclosures and protective covers

IEC 60601-1:1988, Clause 16 applies

17 Separation

IEC 60601-1:1988, Clause 17 applies

18 Protective earthing, functional earthing and potential equalization

IEC 60601-1:1988, Clause 18 applies

19 Continuous leakage currents and patient auxiliary currents

IEC 60601-1:1988, Clause 19 applies, except as follows

IEC 60601-1:1988, Clause 22 applies

23 Surfaces, corners and edges

IEC 60601-1:1988, Clause 23 applies

24 Stability in normal use

IEC 60601-1:1988, Clause 24 applies

25 Expelled parts

IEC 60601-1:1988, Clause 25 applies

26 * Vibration and noise

IEC 60601-1:1988, Clause 26 applies, except as follows

Replacement:

The A-weighted sound power level caused by the equipment shall be measured and disclosed in the instructions for use in accordance to ISO 4871 and ISO 3744 using engineering method grade 2 The A-weighted sound pressure level in accordance with ISO 4871 and ISO 3744 at a distance of 1 m shall also

be disclosed in the instructions for use

Check compliance with the following test

Place the equipment on the sound-reflecting plane and fit the breathing tubes as provided or recommended by the manufacturer

If a humidifier is provided with the equipment, include the humidifier in the test

Connect the standard resistance with 4 mm internal diameter, 40 mm length and outlet angle of 45° (see Figure 101) to the patient connection port

Acoustically insulate the breathing tubes and the gas leaving at the resistance placed at the patient connection port by a suitable means, outside the testing area so that the noise caused by the breathing tube and the gas flow does not interfere with the sound measurement of the equipment

`,,```,,,,````-`-`,,`,,`,`,,` -Dimensions in millimetres

Figure 101 — Standard resistance

Set the equipment to achieve a continuous pressure of 10 hPa (10 cm H2O) at the patient connection port Using the microphone of the sound level meter complying with the requirements of type 1 instruments specified in IEC 61672, measure the sound pressure levels at 10 positions in a hemisphere with a radius of 1m to the geometric centre of the equipment as specified in ISO 3744:1994, 7.2

Calculate the A-weighted sound pressure level averaged over the measurement surface in accordance with ISO 3744:1994, 8.1

Calculate the A-weighted sound power level in accordance with ISO 3744:1994, 8.6

Ensure that the A-weighted background level of extraneous noise is at least 6 dB below that measured during the test

Take measurements using the frequency-weighting characteristic A and the time-weighting characteristic F on the sound level meter in a free field over a reflecting plane as specified in ISO 3744

27 Pneumatic and hydraulic power

IEC 60601-1:1988, Clause 27 applies

28 Suspended masses

IEC 60601-1:1988, Clause 28 applies

29 X-radiation

IEC 60601-1:1988, Clause 29 applies

30 Alpha, beta, gamma, neutron radiation and other particle radiation

IEC 60601-1:1988, Clause 30 applies

31 Microwave radiation

IEC 60601-1:1988, Clause 31 applies

`,,```,,,,````-`-`,,`,,`,`,,` -32 Light radiation (including lasers)

IEC 60601-1:1988, Clause 32 applies

33 Infra-red radiation

IEC 60601-1:1988, Clause 33 applies

34 Ultra-violet radiation

IEC 60601-1:1988, Clause 34 applies

35 Acoustical energy (including ultra-sonics)

IEC 60601-1:1988, Clause 35 applies

37 Locations and basic requirements

IEC 60601-1:1988, Clause 37 applies

38 Marking, accompanying documents

IEC 60601-1:1988, Clause 38 applies

39 Common requirements for Category AP and Category APG equipment

IEC 60601-1:1988, Clause 39 applies

40 Requirements and tests for category AP equipment, parts and components

thereof

IEC 60601-1:1988, Clause 40 applies

`,,```,,,,````-`-`,,`,,`,`,,` -41 Requirements and tests for category APG equipment, parts and components thereof

IEC 60601-1:1988, Clause 41 applies

If sparking can occur under normal or single fault conditions, the materials subjected to the energy dissipation

of the spark shall not ignite under the oxidizing conditions present

Check compliance by observing if ignition occurs under the most unfavourable combination of normal conditions with a single fault condition

44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection

IEC 60601-1:1988, Clause 44 applies, except as follows

44.6 Ingress of liquids

Amendment:

Add (as 2nd sentence, first paragraph):

`,,```,,,,````-`-`,,`,,`,`,,` -Sleep apnoea breathing therapy equipment shall not cause a safety hazard and shall function normally after

the following tests:

⎯ the tests in IEC 60529 for IPX2 or

⎯ the tests in IEC 60529 for IPX1 and the spillage test of 44.3 in IEC 60601-1:1988

Add to test requirement last sentence:

and the sleep apnoea breathing therapy equipment continues to function normally

44.7 * Cleaning, sterilization and disinfection

Amendment (add before the compliance test):

The equipment shall be designed so that the exterior is easily cleaned and the use of contaminant trapping

features is minimized

Any breathing system filter shall comply with ISO 23328-1 and ISO 23328-2

Accessories of sleep apnoea breathing therapy equipment and parts not intended for single patient use shall

be so constructed that the gas pathways can be dismantled for cleaning and disinfection or cleaning and sterilization Processing or (re)processing instructions for the equipment and their parts shall comply with ISO 17664 and ISO 14937

Sleep apnoea breathing therapy equipment or accessories labelled sterile shall have been sterilized using an

appropriate, validated method as described in ISO 14937

Non-sterile device packaging systems shall be designed to maintain products that are intended to be sterilized

before use at their intended level of cleanliness and shall be designed to minimize the risk of contamination

Amendment (add at the end of the compliance test):

If a sterility claim is made, review the accompanying documents for methods of sterilization and disinfection

and comparison to the relevant validation reports

45 Pressure vessels and parts subject to pressure

IEC 60601-1:1988, Clause 45 applies, except as follows

Amendment (add after the first sentence):

This Clause does not apply to sleep apnoea breathing therapy equipment breathing gas pathways

`,,```,,,,````-`-`,,`,,`,`,,` -48 Biocompatibility

IEC 60601-1:1988, Clause 48, except as follows

Amendment (add between “fluids”, and “shall”):

or patient gas pathway,

49 Interruption of the power supply

IEC 60601-1:1988, Clause 49 applies, except as follows

Addition:

49.101 Spontaneous breathing during power failure

The sleep apnoea breathing therapy equipment shall incorporate a means of allowing spontaneous breathing

of the patient when the electrical or pneumatic power supply fails or falls outside the range for normal operation This means may be provided by the masks and accessories specified in ISO 17510-2 (i.e., anti-asphyxiation valves)

50 Accuracy of operating data

IEC 60601-1:1988, Clause 50 applies

51 Protection against hazardous output

IEC 60601-1:1988, Clause 51 applies, except as follows

Check compliance by visual inspection following the instructions for use

51.101 * Maximum steady limiting pressure

The maximum steady limiting pressure at the patient connection port shall not exceed:

⎯ for CPAP and self-adjusting equipment, 20 hPa (20 cm H2O) + pressure stability under normal use and

30 hPa (30 cm H2O) under single fault condition;

⎯ for bi-level positive airway pressure equipment, 30 hPa (30 cm H2O) + pressure stability under normal use and 40 hPa (40 cm H2O) under single fault condition

Check compliance by functional testing under normal use and single fault condition